SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE— 510(k) K023843

Substantially Equivalent

Opus Medical, Inc.

FDA 510(k) clearance K023843 for SMARTSTITCH M-CONNECTOR, MODEL OM-8005; SMARTSTITCH ACTUATION HANDLE, MODEL OM-8500; AND SMARTSTITCH SUTURE CARTRIDGE, Substantially Equivalent on 2003-02-14. Applicant: Opus Medical, Inc..

Clearance details

Applicant: Opus Medical, Inc.
Product code: Code OCW
Advisory panel: Gastroenterology, Urology
Date received: 2002-11-18
Decision date: 2003-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

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Adverse events under product code OCW

product code OCW

Death: 6
Injury: 443
Malfunction: 1,023
Other: 2
Total: 1,474

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.